PMA P960057S001
- Device
- ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL
- Applicant
- Wrightmedicaltechnologyinc
- PMA number
- P960057
- Supplement
- S001
- Product code
- MLQ
- Decision date
- 1998-09-11
- Classification
- Inhibitor, Peridural Fibrosis (adhesion Barrier)
- Generic name
- Inhibitor, peridural fibrosis (adhesion barrier)
- Approval order statement
- The 30-day Notice requested that FDA review a change in the manufacturing process. A Vertrod Thermal Impulse Heat Sealer will be used in place of an Audion Future Jaw clamp pouch sealer to seal the Tyvek pouch containing the aluminum tube of ADCON(R)-L Adhesion Control Barrier Gel. This change does not affect the currently approved Tyvek seal integrity testing method or specification.
Current openFDA PMA Record#
- Device
- ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL
- Applicant
- Wrightmedicaltechnologyinc
- PMA number
- P960057
- Supplement
- S001
- Product code
- MLQ
- Generic name
- Inhibitor, peridural fibrosis (adhesion barrier)
- Decision date
- 1998-09-11
- Decision code
- OK30
- Date received
- 1998-08-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-day Notice requested that FDA review a change in the manufacturing process. A Vertrod Thermal Impulse Heat Sealer will be used in place of an Audion Future Jaw clamp pouch sealer to seal the Tyvek pouch containing the aluminum tube of ADCON(R)-L Adhesion Control Barrier Gel. This change does not affect the currently approved Tyvek seal integrity testing method or specification.